This study is accepting new patients by invitation only

Open-Label Extension Study of Setmelanotide

a study on Obesity

Summary

Eligibility
for people ages 2 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around

Description

Summary

This is an open-label extension study designed to evaluate the long-term safety and tolerability of continued setmelanotide treatment in male and female patients ≥2 years of age who have completed or transitioned from a previous study with setmelanotide for rare genetic, syndromic, or acquired diseases of obesity upstream of the MC4R pathway.

Official Title

Open-Label Extension Study of Setmelanotide in Patients With a Rare Genetic, Syndromic or Acquired Disease of the MC4R Pathway

Keywords

Obesity Associated With Defects in Leptin-melanocortin Pathway, setmelanotide, RM-493, obesity, melanocortin 4 receptor, hypothalamic obesity, Sexual Infantilism, Setelanotide (Open-label)

Eligibility

You can join if…

Open to people ages 2 years and up

  • Males and females ≥2 years of age who have completed a previous setmelanotide clinical study and who have a condition or indication for which Rhythm plans further clinical development.
  • Agree to use a highly effective form of contraception and follow the study contraception requirements throughout study duration and for 90 days after.
  • Demonstrated clinical benefit in the previous setmelanotide study, as determined by the Investigator.

You CAN'T join if...

  • Any gene variant, syndromic, or acquired disease for which setmelanotide is currently approved in the United States (i.e., patients eligible for commercial setmelanotide (IMCIVREE®).
  • Any new or worsening depression resulting in suicidal thoughts and/or behaviors.
  • Discontinuation from a previous setmelanotide study.
  • History or close family history (parents or siblings) of melanoma.
  • Pregnant and/or breastfeeding women

Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • UC San Diego- Rady Children's Hospital
    San Diego 5391811 California 5332921 92123 United States
  • HonorHealth Research Institute
    Scottsdale 5313457 Arizona 5551752 85258 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Rhythm Pharmaceuticals, Inc.
ID
NCT06596135
Phase
Phase 3 Obesity Research Study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated